Enucleation/Evisceration Sizer

Basic Information

• Brand Name: Enucleation/Evisceration Sizer
• Primary DI: 10697660005499
• Version / Model: A1-018
• Company Name: Oculo-Plastik Inc
• Labeler DUNS: 257382580
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-25
• Public Version: 1
• Public Version Date: 2019-12-03
• Public Version Status: New
• Public Device Record Key: 439efcf2-282c-46c3-b4b8-20cbc40dfe49

Device Description

Enucleation/Evisceration Sizer

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63398	Orbital sphere implant sizer	An invasive hand-held manual device with a spherical distal end designed to be used to fill an orbital cavity after enucleation and to measure the size of the cavity to aid selection of an appropriately-sized orbital implant. It is made of metal or synthetic polymer materials and is available in various sizes. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10697660005499	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Outer Diameter	18	Millimeter